Study of the Efficacy of Direct Intratumoral Injection of Absolute Ethanol in Treating Symptomatic Spinal Tumors

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Bethesda,
Maryland20892

Purpose:

Tumors of the spine can be described as primary, meaning that the tumor originated from
cells normally found in the spine, or metastatic, cells from another area of the body that
have spread to the spine. Metastatic tumors are more common than primary tumors. Tumors of
the spine can press against the spinal cord and interfere with information traveling down
from the brain to the nerves of the spinal cord. As a result, patients with spinal tumors
can suffer from loss of movement and sensation within areas of the body below the tumor. In
addition, tumors of the spine are typically painful conditions.
Presently, the treatment of choice for spinal tumors is radiation therapy. However, many
tumors of the spine become resistant to radiation therapy. In addition, because the spinal
cord is often so close to the tumor it can be damaged by the radiation.
Absolute (100%) ethanol is commonly known as "alcohol". It is the same kind of alcohol
found in alcoholic beverages. When pure alcohol is injected directly into a tumor it can
destroy cells and blood vessels. Because of this feature, researchers would like to test
the effectiveness of alcohol in treating patients with spinal tumors.
Researchers believe that intratumoral ethanol injection is a treatment worth studying more
closely because it is minimally invasive, has been proven to be an effective treatment for
other types of metastatic tumors, can be used repeatedly, and does not interfere with other
treatments such as surgery.
In addition to testing the effectiveness of intratumoral ethanol injection, this study will
attempt to determine the causes of pain associated with spinal tumors.

Study summary:

Although radiation therapy is currently the treatment of choice for most spinal metastases,
radioresistant and recurrent neoplasms remain therapeutic dilemmas. Because of the debility
and shortened life expectancy of patients with spinal metastases, treatment that minimizes
blood loss, convalescence, and immobility is critical. The effectiveness and safety of
intratumoral injection of absolute ethanol in eradicating vertebral hemangiomas and hepatic
metastases suggests that intratumoral ethanol injection may also be effective in treating
vertebral metastases. Since most spinal metastases can now be diagnosed with MRI before
they produce spinal instability, it may be possible to treat them with direct ethanol
infusion while preserving spinal stability. Direct ethanol infusion may prove especially
useful in treating symptomatic patients who have received maximal tolerable radiation doses
to the spinal cord. Unlike radiation, which is limited by total radiation dosage, and
intraarterial alcohol, which precludes multiple treatments by occluding the feeding
arteries, intratumoral ethanol injection can be repeated as necessary to obliterate residual
tumor. The potential neurotoxic effects of ethanol can be avoided by using CT-guidance to
position the needle, by monitoring a test injection with contrast, and by injecting ethanol
slowly and in small volumes. Intratumoral injection of absolute ethanol warrants a clinical
trial because it is minimally invasive, has been effective in treating peripheral
metastases, can be used repeatedly, and does not preclude other types of treatments such as
open surgery.
As well as testing the therapeutic efficacy of intratumoral ethanol for spinal metastasis,
this protocol seeks to elucidate the pathophysiology of pain from spinal metastasis.
Correlation of changes in pain with changes in tumor size and tumor pressure pre- and
post-ethanol injection should indicate the relationship of pain to tumor size and pressure.
A group of 11 patients with vertebral hemangiomas has been treated with intratumoral ethanol
at the NIH. This protocol will accrue patients with vertebral hemangiomas who require
treatment with intratumoral ethanol and will continue the post-treatment evaluation of
patients previously treated with intratumoral ethanol at the NIH.

Criteria:

Patients must have a vertebral tumor documented by MRI.
Vertebral height must be at least 50 percent of adjacent vertebrae.
Patients must be symptomatic from their spinal tumor. Treatment attempts to reduce the
size of, or eliminate, their tumors and to relieve their symptoms. The treatment of the
vertebral tumor must be indicated based on the patient's condition.
Prior surgical or radiation therapy for the vertebral tumor will not result in exclusion
from the study if there is radiographic evidence of tumor and there is evidence of
persistent local pain, epidural compression, or neurological deterioration related to the
vertebral tumor.
The patient must be able to comprehend the risks of the therapy and must be able to give
informed consent.
Pregnancy will exclude participation due to the radiation exposure involved in this
protocol.
Bleeding disorders will exclude a patient from the protocol unless the disorder can be
corrected prior to treatment.
Patients must have no contraindications to MRI scanning.
Patients undergoing ethanol injection in the x-ray department must be able to lay prone
for at least one hour with intravenous sedation and analgesia.
Patients whose tumors have not responded to radiation therapy will be candidates for
ethanol infusion.
Patients with tumors in areas that have received maximal radiation doses to the spinal
cord will be candidates for ethanol infusion.
Patients whose poor general condition precludes open surgery will be candidates for
ethanol infusion.
Patients who wish to avoid the morbidity and potential mortality of open surgery will be
candidates for ethanol injection.
Patients with radioresistant tumors such as melanoma or prostate carcinoma are candidates
for ethanol infusion even if they have not undergone prior irradiation.
Patients with radiation-sensitive spinal tumors such as breast, kidney, and lung
carcinoma, lymphoma, myeloma, Ewing's sarcoma, neuroblastoma, seminoma will not be entered
into the protocol unless their tumors have either responded to radiation or lie at spinal
cord levels that have already received maximal tolerable radiation doses.
Patients with less than a 2 month life expectancy will be excluded.
Patients with symptomatic vertebral metastases at more than 3 spinal levels will be
excluded.
Patients with asymptomatic vertebral metastases will be excluded.

NCT ID:

NCT00001417

Primary Contact:

N/A

Backup Contact:

N/A

Location Contact:

Bethesda, Maryland 20892United States

There is no listed contact information for this specific location.

Site Status: N/A

Data Source: ClinicalTrials.gov

Date Processed: June 25, 2018

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